Thermo Fisher Scientific Manager, IT Quality and CSV QA in Cambridge, Massachusetts
When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.
Location/Division Specific Information
'VVS-PSG, part of Thermo Fisher Scientific' is a dynamic gene and cell therapy contract development and manufacturing organization that is looking for leaders to bring the highest quality processes, products and testing to our clients. Our staff members are committed to making a difference in our organization, for our client partners and the patients we serve. We seek individuals with proven competencies and strong character to help lead our organization now and into the future.
This candidate may be located at any of the VVS NA Locations (Alachua, FL, Cambridge, MA, Lexington, MA or Remote)
How will you make an impact?
The Manager of IT Quality and CSV will be responsible for providing Quality Assurance leadership and support as the IT Quality liaison for computerized system regulatory assessments, validation, change control, process improvements and compliance governance at all applicable points of the System Development Lifecycle and help facilitate an environment for inspection readiness. This individual will represent Quality on IT projects in support of the System Development Lifecycle activities, consult on the authoring and conformance of SDLC deliverables and activities regarding procedures, policies and current regulations, provide QA oversight for system related issues, and employ risk-based methodology. Additionally, the individual will focus on ensuring consistent policy administration, implement key improvement initiatives and solve compliance issues in partnership with business owners. The Manager IT Quality and CSV will interface with a diverse set of departments including IT, Site Based Quality Control, Manufacturing, Automation and Validation groups. The individual will drive IT compliance and data integrity culture in partnership with the sites.
What will you do?
Approve system life cycle deliverables (SDLC) and activities to ensure that procedures and methodologies are followed, and that appropriate and complete documentation is captured.
Represent IT Quality on all assigned IT projects in support of SDLC activities, including Periodic Reviews and associated change requests
Consult on the authoring and conformance of SDLC deliverables and activities in regard to company SOPs, policies and current regulations
Provide guidance and support to IT personnel in their SDLC efforts, to ensure compliance
Provide quality assurance oversight for system related issues
Act as a high-level technical resource to IT quality and customer base for interpretation of policy, review and approval of technical documents, and high-level decision making
Support and train site-based Quality teams on CSV and SDLC methodology
Provide Subject Matter Expertise in the Change Management process including risk assessments during system implementations.
Employ risk-based methodology, where feasible and achievable
Support internal and client audits and regulatory inspections
Provide support in other quality system related activities including quality exceptions and change control
Manage and develop a team of Quality professionals responsible for ensuring Quality oversight of CSV and SDLC in compliance with VVS Quality Systems
How will you get here?
BS - in Life Sciences, Engineering or IT related discipline - required.
10+ years of experience GMP regulated industry, preferably biotech, pharmaceutical, or medical device
5 years experience working in an IT Quality role - preferred.
Experience in leading or managing teams
Strong Knowledge of IT Controls methodologies, including GAMP5
Solid understanding of GxP guidance, including 21 CFR Part 11, Annex 11 and data integrity experience with system validation across GxP landscape, specifically GMP applications
Knowledge of the IT system development life cycle and software quality assurance in a regulated environment
Knowledge of general networking concepts and IT best practices
Knowledge, Skills, Abilities
Ability to work both independently and with teams at various levels in the organization
Ability to work in a very dynamic environment with a clear sense of urgency
Ability to multi-task and meet deadlines in a fast-paced environment
Excellent organizational skills and attention to detail and accuracy
Strong communication skills, both verbal and written as well as capable of presenting the right level of information to management
Strong analytical and organizational skills
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
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